300 combination drugs banned; details to be made public shortly

The Union Health Ministry on Monday banned the manufacture and sale of more than 300 combination medicines whose details would be announced shortly. The ban follows the recommendation of an official committee set up in 2014 to review more than 6,000 combinations that had entered the market based only on state regulators’ approval. Policymakers gave pharmaceutical companies a chance to retroactively prove the safety and efficacy of these drugs by submitting data on their drugs.

Indianmandarins has learnt that the move is aimed at curbing the misuse of combination medicines as about half the drugs sold in in the domestic market in 2014 were so called “fixed dose combinations.”

The committee was tasked with classifying the drugs into rational, irrational, and those that need further studies. Based on responses of drug companies and assessment of products, more than 300 drugs have been prohibited.